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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00893-1
Product Name/Description TOPPER Xtra Absorbent Dressing Pads, Sterile

Product codes: P55263 and P55264 – all pack sizes

All lots affected

ARTG number: 168750
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 21/08/2014
Responsible Entity KCI Medical Australia Pty Ltd
Reason/Issue The manufacturer, Systagenix has become aware that the sterility of some product may be compromised due to small holes in the bottom layer of the primary pouch; its subsequent use may therefore pose a potential risk of localised infection.
Recall Action Recall
Recall Action Instructions Users are advised to discontinue use of affected stock and monitor any patients who are using, or have recently used, any of the affected products for signs of localised infection, including heat, pain, redness or swelling around the wound or increased wound drainage. If symptoms are presented then the clinician should treat appropriately. This action has been closed-out on 1/06/2016.
Contact Information 1300 524 822 - KCI Customer Service